About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.Stay Connected
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I am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Monthly Archives: March 2009
President Obama’s Forum Health Reform – Attendees
There was not much light shed on the content and format of the Health Care Summit being held by the White House today, but here is the roster and schedule of breakout sessions from Whitehouse.gov… White House Forum on Health … Continue reading
Posted in Current Affairs
1 Comment
The Supremes and the Pre-emption Thing
Yesterday, the Supreme Court issued a ruling in the case of Wyeth v. Levine, a case where a drug manufacturer argued that the act of FDA approval and a label – as an act of a federal agency – pre-empted … Continue reading
Posted in Current Affairs
1 Comment
GAO Urges More FDA Control Over Dietary Supplements
There are a few very specific places to look if you want to read the tea leaves of potential reforms by Congress. One is the Oversight committee correspondence with the agency that regulates your area of interest as well as … Continue reading
Posted in Vitamins and Supplements
2 Comments
Sebelius Accepts HHS – If Winter is Near – Can Spring Be Far Away – Who Will Be Obama’s FDA Commissioner?
The news was out on Saturday and carried by the New York Times on Sunday that Governor Kathleen Sebelius of Kansas has accepted offer from President Obama to head Health and Human Services. (See the previous posting last week on … Continue reading
Posted in Current Affairs
3 Comments